Kornimate/medical-research-clean huggingface dataset:
assessing women's attitudes about the risk of infertility related to adjuvant therapy for early breast cancer

Conditions: Breast Cancer; Psychosocial Effects of Cancer and Its Treatment; Sexual Dysfunction and Infertility; Sexuality and Reproductive Issues

Summary: rationale: adjuvant therapy given after surgery for early breast cancer may cause infertility. assessing young women's attitudes and feelings about the risk of infertility may help improve the ability to plan effective treatment. purpose: this clinical trial is studying young women's attitudes and feelings about the risk of infertility related to adjuvant therapy for stage i or stage ii breast cancer.

objectives: * determine the attitude toward the risk of infertility related to adjuvant therapy in women with early breast cancer. * correlate, if possible, the patient's attitude with the fact that the patient already has children or the time interval between the date of breast cancer diagnosis and the date of study participation. outline: this is a multicenter study. patients complete a questionnaire administered by a nontreating physician. projected accrual: a total of 385 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed prior or current diagnosis of breast cancer * stage i or ii * no relapsed disease * no evidence of infertility * regular menses or regular hormonal contraception use for the past 3 months * hormonal status: * not specified patient characteristics: age * 35 and under at diagnosis sex * female menopausal status * premenopausal performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified other * no psychological, familial, sociological, or geographical condition that would preclude study compliance prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * see disease characteristics radiotherapy * not specified surgery * not specified

Keywords: sexual dysfunction and infertility sexuality and reproductive issues psychosocial effects of cancer and its treatment stage ii breast cancer stage ia breast cancer stage ib breast cancer
clinical evaluation of different resin composite restorations

Conditions: Dental Caries

Summary: posterior resin composite is challenging esthetic restoration. patients seek for durable, esthetic and functional restorations in molars. one of the major problems is polymerization shrinkage. some materials were developed to overcome the polymerization shrinkage, among them bulk fill resin composite which have been developed to reduce the shrinkage stress during polymerization and offer much greater depth of cure. this is achieved by the addition of fillers such as barium aluminum silicate filler, ytterbium trifluoride and mixed oxides. furthermore, a prepolymerized fillers have been added with silanes to reduce shrinkage stress. so, the objective of this trial is to clinical evaluate and compare clinical performance of bulk fill vs incremental filling technique.


Eligibility criteria:
inclusion criteria: inclusion criteria of participants: * male gender * good oral hygiene * only cooperative patient * medically free patient * age range 18-24 inclusion criteria of the teeth: * vital teeth with no periapical lesion or radiolucency. * prepared cavity with no undermined enamel walls. * functioning tooth with presence of an opposing. * healthy periodontium. exclusion criteria: * exclusion criteria of participants: * old age patients * patients have systemic disease or sever medically compromised * patients with bruxism, clenching or temporomandibular joint disorder. * por oral hygiene exclusion criteria of teeth: * teeth with periapical lesions. * teeth with visible cracks. * teeth with mobility. * non-functioning tooth with no opposing tooth. * heavy occlusion or signs of sever attrition. * tooth with periodontal affection.

Keywords: composite resin
dalfampridine for imbalance in multiple sclerosis

Conditions: Multiple Sclerosis; Fatigue

Summary: dalfampridine is a new medication that was fda approved in 2010 to improve walking speed in people with multiple sclerosis (ms). people with ms walk slowly in part because ms damages the myelin insulation around nerves which slows conduction of messages from the brain to the leg muscles. dalfampridine works by improving conduction in nerves with damaged myelin. recent research indicates that imbalance in ms is in large part caused by poor conduction by the nerves that transmit information about the position of the legs to the brain. it is therefore likely that, by improving nerve conduction, dalfampridine will also improve imbalance in people with ms. dalfampridine will be administered in this study by the same route (oral), dosage (10mg), and frequency (every 12 hours) approved by the fda to improve walking speed in people with ms. the proposed pilot study will examine the effects of dalfampridine on imbalance in 24 subjects with multiple sclerosis (ms) and imbalance. this small pilot study will help to show if dalfampridine improves imbalance in ms and will guide the design and implementation of a larger full scale study to definitively determine if dalfampridine improves balance and prevents falls in people with ms.


Eligibility criteria:
inclusion criteria: * age 20- 59 years, * able to walk at least 100m without an aide or with unilateral assistance * prolonged apr latencies (≥ 1sd \> mean for healthy people in this age range) or, * reduced balance-related activity (abc scores ≤ 85%), * abnormal trunk range of motion (horizontal), trunk range of motion (frontal), turning duration, cadence, double support time, stride length or gait cycle time (outside 1sd of the average for healthy people in this age range) exclusion criteria: * currently taking dalfampridine (any within the last 2 weeks), * cause(s) of imbalance other than ms, * impaired renal function (creatinine clearance ≤50ml/min), * seizure disorder * pregnancy or breast feeding

Keywords: multiple sclerosis postural balance gait fatigue
prevalence of chagas disease in immigrant patients with conduction abnormalities on electrocardiogram

Conditions: Chagas Disease

Summary: chagas disease is endemic to the americas, infecting between 16-18 million individuals. in immigrant populations in the united states from endemic areas, it is estimated up to 4.9% may be asymptomatic carriers of trypanosoma cruzi, the organism which causes chagas disease. between 10-20% of these patients progress to development of end-stage cardiomyopathy with a high associated morbidity. following acute disease, patients enter into an indeterminate phase which can last 10-20 years. the earliest sign of cardiac involvement usually is electrocardiogram abnormalities. the most common abnormality is right bundle branch block (rbbb), followed by left anterior fascicular block (lafb), and left bundle branch block (lbbb). recent studies have shown that treatment of patients at this stage with antiparasitics may delay the progression of overt cardiomyopathy. at the university of california, los angeles, there is a large population of immigrant patients from countries endemic to chagas disease. the researchers propose that screening patients with conduction abnormalities on electrocardiogram may be a potentially useful method to identify patients with early cardiac manifestations of chagas disease. the researchers hope to enroll approximately 300 individuals with rbbb, lafb or lbbb on electrocardiogram to determine the incidence of chagas disease in this patient population.


Eligibility criteria:
inclusion criteria: * one of the following ekg abnormalities: * complete or incomplete right bundle branch block (rbbb) * left anterior fascicular block (lafb) * left bundle branch block (lbbb) * residence at any point in past in an endemic area (any country in central or south america or mexico) for at least 12 months. * age \>18 and \<60. exclusion criteria: * ejection fraction \<40% * symptomatic heart failure * documented coronary artery disease

Keywords: chagas trypanosoma cruzi
non interventional post marketing programme in acromegaly

Conditions: Acromegaly

Summary: the purpose of this study, is to assess the safety and local tolerability of the long-term use of somatuline autogel when administered by patients or their partners ("home injection group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (hcp) ("reference group").


Eligibility criteria:
inclusion criteria: * the patient must give written (personally signed and dated) informed consent for their data to be included in the database for this post-marketing surveillance programme and any subsequent analysis. * the patient must have been receiving treatment with somatuline autogel at a stable dose for at least 4 months. * the patient must have a diagnosis of acromegaly. * the patient must be at least 18 years of age. * for patients receiving or intending to receive somatuline autogel by home injection: * the patient must be able to store somatuline autogel safely in a refrigerator in their own home and either collect it from their general practitioner/pharmacy on a monthly basis, or receive the medication by a home delivery service. exclusion criteria: * the patient is pregnant or breast-feeding, unless continued treatment with somatuline autogel is clearly needed (as determined by the treating clinician).
acute porphyria biomarkers for disease activity

Conditions: Acute Intermittent Porphyria; Hereditary Coproporphyria; Variegate Porphyria

Summary: the long term objective of the research is to identify new biomarkers of disease activity in the human acute porphyrias. this pilot study is intended to provide pilot and feasibility data needed to plan larger and more definitive future studies.

this translational pilot research is based on preliminary results using animal models. the investigators will collect samples of blood, urine and feces from up to 50 participants with well documented acute porphyrias, at 2 expert sites that are members of the porphyrias consortium. collection and analysis of these samples will be used to assess feasibility of performing such studies in humans with acute porphyrias, recognizing that these disorders are more heterogeneous than reproduced in animal models, and affect individuals who cannot all be studied simultaneously and in large groups. therefore, we will assess the feasibility of methods for collecting, processing, storing and shipping samples at multiple study sites for later biomarker analysis. larger and more definitive studies of biomarkers will be designed and implemented based on data and experience from this pilot-feasibility study.

Eligibility criteria:
inclusion criteria: * documented diagnosis of acute porphyria. 1. for aip: elevation in urine pbg, with normal or only slight increases in plasma and fecal porphyrins. most (\~90%) will have deficient activity of erythrocyte pbgd. 2. for hcp: elevation in urine pbg, with substantial increases in fecal porphyrins (almost entirely coproporphyrin iii). in the absence of skin photosensitivity, most will have normal or only slight increases in plasma porphyrins. 3. for vp: elevation in pbg, with substantial increases in fecal porphyrins (mostly coproporphyrin iii and protoporphyrin), increased plasma total porphyrins and a fluorescence emission maximum of diluted plasma at neutral ph near 626 nm. exclusion criteria: * another medical condition that might confound the results, as judged by the investigator

Keywords: porphyria biomarkers
mechanical ventilation and respiratory muscle work of breathing in acute respiratory distress syndrome (ards) patients

Conditions: ARDS

Summary: the purpose of this study is to demonstrate that mechanical ventilation guided by the diaphragm emg signal (also know as neurally adjusted ventilatory assist \[nava\]) is superior compared to pressure support and pressure control ventilation.


Eligibility criteria:
inclusion criteria: * intubated, mechanically ventilated patients * meeting criteria for ards * mean arterial blood pressure \> 65 mmhg (with or w/o vasopressors) exclusion criteria: * pregnancy * increased intracranial pressure * contra-indication naso-gastric tube * diagnosed neuro-muscular disorder * recent (\<12 hours) use of muscle relaxants * exclusion from sedation interruption protocol as used in our institution * open chest or- abdomen * very high inspiratory flow rate during supported ventilation * inability to obtain informed consent
a clinical trial to verify the efficacy and safety of electric phlegm suction system

Conditions: Other Specified Respiratory Disorders

Summary: manual airway aspiration is a task performed by a nurse or caregiver and if the nursing/care work is overloaded, it has the disadvantage that airway aspiration cannot be performed an appropriate number of times according to the needs of the patient. therefore, an electric phlegm suction system that can compensate for the shortcomings has been developed. the purpose of this clinical trial is to compare and evaluate the efficacy and safety of the test device by applying the unmanned electric phlegm suction system procedure using an investigational device (lmeca.a1000) and the conventional manual airway aspiration procedure to the patients who received mechanical ventilation through the artificial airway in this clinical trial.


Eligibility criteria:
inclusion criteria: * those aged ≥19 among the in-patients in the intensive care unit of the study site. * patients who have been applied with mechanical ventilation through the artificial airway such as tracheal intubation or tracheotomy and have maintained pao2/fio2 values above 100mmhg. * patients whose application time of mechanical ventilation does not exceed 36 hours * those who are expected to see continued application of mechanical ventilation for at least 72 hours after participating in this study exclusion criteria: * the subject or a legally acceptable representative refuses to participate in the study * those who have become pregnant or are planning to become pregnant during the study period * patients who need to maintain their plateau pressure with the mechanical ventilation setting of fio2 exceeding 80% or exceeding pplat of 30cmh2o. * patients with severely lowered immune function such as advanced hematologic malignancy, bone marrow transplantation failure, agranulocytosis, and absolute neutrophil count (anc) of \<500/mm3 * those with unstable cardiovascular conditions such as arrhythmia accompanied by hemodynamic instability and severe hypoxemia * those who continue to bleed due to hemorrhagic causes, including multiple traumas or thrombocytopenia * if the patient is scheduled for or had performed a solid organ transportation on the day of study participation, or self-recovered through cardiopulmonary resuscitation (cpr) * patients with pulmonary disease accompanied by hemoptysis * in addition, if the medical staff decides that it is not appropriate to apply the investigational device to the subject or perform bronchoscopy
neurotrophic factors, tight junction proteins, and cytokines in ibs

Conditions: Irritable Bowel Syndrome; Tight Junction Alteration; Pathophysiology

Summary: to evaluate the role of neurotrophic factors (ngf, gdnf, trpv-1), to quantity tight junction proteins (zo-1, occludin, claudin) and cytokines (il-8, tnf-a, il-1b) in the colonic mucosa of ibs patients and also clarify sex differences in the pathophysiology of ibs.


Eligibility criteria:
inclusion criteria: * control group those who were between 18 and 80 years old and did not have any abnormalities in colonoscopy * irritable bowel syndrome group patients who diagnosed as irritable bowel syndrome according to the rome iii criteria exclusion criteria: * history of ibd * abdominal operation * severe systemic disease * malignancy,

Keywords: irritable bowel syndrome subtype tight junction sex
gene expression in liver allograft rejection and recurrent hepatitis c

Conditions: Liver Transplantation

Summary: acute cellular rejection is relatively common after liver transplantation, typically does not affect graft survival, and is not associated with the development of chronic rejection. acute cellular rejection is diagnosed when liver enzymes and/or liver function tests are elevated when compared to baseline. the only means of differentiating acute rejection from other liver pathologies is with a liver biopsy. however, even with this invasive diagnostic procedure, it may be difficult to distinguish acute rejection from another disease process, such as injury caused by the hepatitis c virus (hcv) from the native liver. this study will evaluate whether certain patterns of biomarkers in the peripheral blood and/or liver tissue of a liver transplant recipient can be used to determine if the transplanted liver is being rejected by the recipient or sustaining hcv injury. diagnostic biomarkers that are specific for acute rejection and informative of the severity of hcv recurrence could allow for modulation of immunosuppression therapy and treat the clinical condition without the need for invasive liver biopsies.


Eligibility criteria:
inclusion criteria: * specimens derived from subjects enrolled in the itn030st study. * availability of adequate biopsy specimens with corresponding blood and/or serum collected within a 10 day window of a for-cause or protocol biopsy. exclusion criteria: * withdrawal of consent for the itn030st study. * absence of consent in the itn030st study for the collection and storage of samples of blood and tissue for future research studies.
comparison of secretin-enhanced magnetic resonance cholangiopancreatography (s-mrcp) to endoscopic pancreatic function test (epft) in diagnosing pancreatic exocrine insufficiency

Conditions: Pancreatic Cancer

Summary: the aim of our study is to evaluate s-mrcp, in comparison to direct pancreatic function, to measure pancreatic exocrine function in patients who have symptoms suspicious for insufficiency. we hypothesize that s-mrcp imaging parameters will correlate well with the direct pancreatic exocrine functioning.

surgical resection offers the only hope of cure for pancreatic adenocarcinoma. while perioperative mortality rates have declined in recent years, pancreatic resection is still associated with significant postoperative malnutrition, maldigestion, and glucose intolerance, mostly as a result of pancreatic insufficiency. quantifying individual pancreatic function remains a challenge, but is essential in improving the survival and quality of life of pancreatic cancer patients. secretin-enhanced magnetic resonance cholangiopancreatography (s-mrcp) has recently emerged as a widely-accepted noninvasive technique to assess morphological changes in pancreatic ducts, as well as functional secretory capacity of the gland. the aim of our study is to evaluate s-mrcp as a means to evaluate for pancreatic exocrine insufficiency. this will be a prospective study of twelve patients who have undergone pancreatic resection and who have symptoms of abdominal pain, steatorrhea or weight loss. we will be comparing quantitative parameters of s-mrcp (maximal change in pancreatic duct diameter and volume before and after secretin administration) with endoscopic pancreatic function testing (maximal bicarbonate concentration in duodenal aspirate after secretin administration).

Eligibility criteria:
inclusion criteria: * 18 years of age and older * tissue-confirmed diagnosis of pancreatic adenocarcinoma * undergone surgical resection for adenocarcinoma no less than 3 months prior to enrollment * report significant abdominal pain/bloating or steatorrhea \>3x/week or demonstrate weight loss corresponding to \>10% of pre-surgery bmi. * scheduled for egd/eus to investigate the above clinical indicators. exclusion criteria: * history of any radiation therapy to the abdomen prior to surgery * any contraindication to mri, including but not limited to implanted metal devices (e.g. pacemaker, berry aneurysm clips, neural stimulator, cochlear implants, or metal in the eye) * presence of pancreatic duct stent * treatment with an investigational drug within 1 month prior to the day of the study drug administration * current enrollment in any other interventional study * creatinine greater than 2.0 * significant liver disease, liver masses, or evidence of portal hypertension * pregnancy * history of sensitivity to secretin * unwilling or unable to sign informed consent

Keywords: pancreatic cancer pancreatic resection synthetic human secretin secretin-enhanced mrcp endoscopic pancreatic function test pancreatic exocrine insufficiency
influence on erythropoetin-level by xenon

Conditions: Healthy Volunteers

Summary: the purpose of this study is to analyze the effect of xenon-inhalation on erythropoetin-level in blood of healthy volunteers and to determine the efficient time of inhalation. hypothesis: xenon-inhalation enhances erythropoetin-levels in blood

xenon-gas is an approved anesthetic by the emea and is used for a balanced anesthesia in combination with opioids for adults with a american society of anesthesiology classification asa ≤ iii. several clinical and pre-clinical studies have shown a positive effect of xenon on several organ functions such as in brain, kidneys and heart. in two studies, an enhanced expression of hypoxia inducible factor-1α (hif-1α) could be shown in animal kidneys and kidney cells. interestingly, hif-1α leads to an enhanced formation of erythropoetin (epo). this might result in an enhanced oxygen transport capacity and an enhanced oxygen-level after xenon-treatment. aim of the project is to analyze the effect of xenon-inhalation on circulating erythropoetin-level in blood of healthy volunteers in a randomized controlled pilot study. besides, other positive stimulating factors for erythropoiesis (such as hifa stabilizing factors) and growth factors (such as fibroblast growth factors (fgfs), hepatocyte growth factor (hgf), mechano growth factors (mgfs), platelet-derived growth factors (pdgfs), vascular endothelial growth factors (vegfs)) shall be analyzed.

Eligibility criteria:
inclusion criteria: * male subjects * age: \> 18 years * legally competent to sign * without any known medical condition or medication prescribed at the university hospital rwth aachen, germany * persons that are able and willing to understand and follow the instructions of the study personnel * signed informed consent exclusion criteria: * smoker, alcoholic or person who regularly consumes drugs or medication * persons with a medical condition that is contraindicated with the planned treatment * known hypersensitivity against xenon * persons not legally competent to sign * simultaneous participation at any other trial * blood-loss due to trauma during the period of the study or 2 months previous * blood donation during the period of the study or 2 months previous

Keywords: xenon-inhalation erythropoetin pharmakokinetic pharmacodynamic hemodynamic parameters inflammatory parameters growth factors oxidative stress parameters